From the earliest recorded history of mankind, men have suffered from all manner of disease and injury. Whether it is found on the paintings and petroglyphs of early cave dwellers and cliff dwellers or in the 4700-year-old Huang Di Nei Jing (Yellow Emperor's Classic of Internal Medicine), there is a long history of Man's attempt to treat diseases and injuries. Most of this early medicine consisted of herbal remedies and, in the case of the ancient Chinese, acupuncture. The basis of modern western medicine has been formed in a large part from what was learned from the ancient Native Americans, Asians, Indians and Europeans. A large percentage of effort in medical research is spent on developing a scientific understanding of how some of these early remedies work.
Probably the most effective and yet least understood medical practice is acupuncture. Acupuncture dates back more than 5000 years. Shen Nung developed the theory and early practice of acupuncture. Shen Nung developed several theories on the function of the body, including the first concepts of circulation, pulse and the heart. He also developed the theory of an energy force flowing through the body along meridian lines. His term for this energy force was Qi (pronounced chee). Shen Nung theorized that Qi affects all aspects of a person, including emotional, spiritual and physical health. A person's health is affected by the flow of Qi in the body along with the universal forces of yin and yang. To maintain good health, it is necessary to maintain a balance. Shen Nung's meridian lines are divided among yin meridians and yang meridians. In general yin meridians flow up (from the earth) along the inside of the legs and arms while yang meridians flow down (from the sky/sun) along the outside of the arms, back and legs. Normally Qi energy constantly flows up and down along the meridian lines. When something happens to interrupt or block the flow of Qi energy, a disease state occurs.
Acupuncture meridians can best be characterized as ‘channels’, or “vessels” through which Qi energy flows and are sometimes associated with a clear, colorless liquid that flows within them (Thie, J. F., “A New Approach for Restoring our Natural Energies”; 1979.). Meridians and acupuncture points have also been characterized by lines and points of low electrical resistance located in the epidermis. These areas have been associated with the presence of gap junctions. These intercellular junctions are the basis of intercellular communications (Jingyu, F., et al., Am. J. of Acupuncture, 18(2), 163-170, 1990) Other researchers have suggested that meridians comprise electrically polarized molecules, such as water clusters having a permanent electrical dipole moment (Lo, S. Med. Hypotheses, 58(1), 72-76, 2002).
The understanding of the properties and characteristics of Qi energy and the meridians in which it flows has been gained primarily from the collective experience of many generations of acupuncture practitioners. However, recent efforts to detect the meridians and measure energy flow have been reported in the literature (Lo, supra; Jingyu, et al., supra; Zong-xiang, Z., Am. J. of Acupuncture, 9(3), 203-216, 1981; Darras, J-C., et al., Am. J. of Acupuncture, 20(3), 245-256, 1992) all of which are incorporated herein in their entirety to the extent not inconsistent herewith). For example, Lo used infrared imaging to show the effect of acupuncture on relieving pain by stimulating an acupuncture point (on a meridian associated with the pain area) that is far from the area of pain (Lo, supra). Darras et al. have also studied meridians by injection of radioactive tracers into traditional acupuncture points and studying the migration of the tracer. Results indicate that the tracer migrates preferentially along pathways that coincide with meridians described by traditional Chinese medicine. These pathways are reported as distinct from lymphatic or vascular pathways as shown by control experiments in which tracer that is injected in a non-acupuncture site does not show such preferential migration (Darras et al., supra).
Acupuncture meridians are located below the surface of the skin and are interconnected deep within the body. As mentioned above, they are arranged in two groups, based upon direction of flow. Yin meridians are associated with solid organs of the body while Yang meridians are associated with hollow organs. The twelve commonly acknowledged major meridians are listed in Tables 1 and 2. Numerous references illustrate the position of the meridians (see, e.g. Thie, J. F., “A New Approach for Restoring our Natural Energies”; 1979.) Numerous ‘minor’ meridians also exist.
TABLE IYang MeridiansStomachFrom the right eye through the right chest,right stomach, down the front of the right legto the right foot toesSmall IntestineFrom the left hand, down the outside of left armto back of left shoulder and up left side of faceto the left earBladderFrom the left eye up over the head, down the neckdown the central and left of back down the left legto the left foot and toesTriple warmerFrom the left hand, down the underside(elbow) of theleft arm through the triceps area to the shoulder andup the left side of the neck to the left eyeGall BladderFrom the left eye over the top of the head, down theback of the neck, down the left side of the torso,through the outside of the left leg and into theleft foot.Large IntestineFrom the tip of the left index finger down theoutside of the left arm through the left shoulder upthe left side of the throat and into the nose
TABLE IIYin MeridiansSpleenFrom the left big toe up the front of the left leg,up the left front side of the torso to just below theleft arm pitHeartFrom the left arm pit up the underneath side of theleft arm to the tip of the small fingerKidneyFrom the bottom of the left foot to the back of theleft heel, up the back inside of the left leg, upthe center of the front of the torso to just leftof the sternumPericardiumFrom the right upper quadrant of the chest to theshoulder, up the under side of the right arm to thetip of the second finger on the right handLiverFrom the tip of the big toe on the left foot, backalong the inside of the left foot, up along the insideof the left leg up along the left front portion of thelower torso and to the left front torso midway up thetorsoLungFrom a point on the left front portion of the chest, upto the left shoulder, up the inside of the left arm tothe tip of the left thumb
The meridians are believed to all be connected end to end with each other such that Qi energy can flow from one to the other and form a continuous loop. They are arranged in the following order: gall bladder connected to liver connected to lung connected to large intestine connected to stomach connected to spleen connected to heart connected to small intestine connected to bladder connected to kidney connected to pericardium connected to triple heater connected to gall bladder
Several therapies have been developed based on the flow of Qi energy along the meridians. These therapies are used to treat a wide variety of health conditions, mostly dealing with pain and healing of wounds and other more chronic conditions. Acupuncture is the first and most common of these therapies. It consists of inserting and manipulating small sharp needles at points, or nodes (acupuncture points) along the meridians that are considered blocking points to the flow of Qi. The needles act to unblock these meridians, restore the flow of Qi and restore health. Similar therapies are practiced where other methods are used to unblock these acupuncture points. Acupressure applies pressure to blocking points to restore the flow of Qi. Similarly, electrical stimuli, magnetic stimuli and point light sources are applied to acupuncture points to unblock meridians and restore the flow of Qi energy.
In western medicine, acute or chronic pain associated with arthritis, injuries and other non-specific pain conditions is often treated by manipulating the flow of blood. Changing the temperature of tissue being treated most often does this. It is a commonly held belief that heating a part of the body can increase blood flow to that part of the body, and furthermore that increasing blood flow also increases the rate of healing. There are many products that work on this premise, including heating pads, hot water bottles, heat lamps and light therapy devices.
In western medicine today, pulsed monochromatic light of various wavelengths is used as a therapy for the treatment of various muscular and skeletal disorders, including pain, swelling and injuries. This therapy is in limited use by chiropractors, physical therapists, sports medicine specialists, holistic medicine practitioners and medical doctors. Although the mechanisms of action are not well understood, it is generally held that pulsed light therapy in the visible and infrared range is effective by a combination of tissue heating, which increases localized circulation, and by photobiological effects (U.S. Pat. No. 6,290,713 of Thomas A. Russell for “Flexible Illuminators for Phototherapy” issued Sep. 18, 2001; U.S. Pat. No. 6,187,029 of Shapiro et al. for “Photo-thermal Treatment Device” issued Feb. 13, 2001; U.S. Pat. No. 6,096,066 of Chen and Wiscombe for “Conformal Patch for Administering Light Therapy to Subcutaneous Tumors” issued Aug. 1, 2000; U.S. Pat. No. 5,616,140 of Prescott for “Method and Apparatus for Therapeutic Laser Treatment” issued Apr. 1, 1997; U.S. Pat. No. 5,913,883 of Alexander and Brighton for “Therapeutic Facial Mask” issued Jun. 22, 1999; U.S. Pat. No. 5,358,503 of Bertwell and Markham for “Photothermal Therapeutic Device and Method” issued Oct. 25, 1994; U.S. Pat. No. 4,761,047 of Mori for “Light Rays Radiation Cloth for Medical Treatment” issued Aug. 2, 1988; U.S. Pat. No. 5,989,283 of Wilkens for “Irradiation Device, Especially for the Cosmetic, Diagnostic, and Therapeutic Application of Light” issued Nov. 23, 1999; U.S. Pat. No. 5,447,528 of Gerardo for “Method of Treating Seasonal Affective Disorder” issued Sep. 5, 1995; U.S. Pat. No. 4,671,285 of Walker for “Treatment of Human Neurological Problems by Laser Photo Simulation” issued Jun. 9, 1987; U.S. Pat. No. 6,249,698 of Parris for “Infrared Radiation Therapy Device” issued Jun. 19, 2001; U.S. Pat. No. 5,549,660 of Mendes et al. for “Method of Treating Acne” issued Aug. 27, 1996; U.S. Pat. No. 5,259,380 of Mendes et al. for “Light Therapy System” issued Nov. 9, 1993; U.S. Pat. No. 4,930,504 of Diamantolpoulos et al. for “Device for Biostimulation of Tissue and Method for Treatment of Tissue” issued Jun. 5, 1990; U.S. Pat. No. 5,800,479 of Thiberg for “Device for Medical External Treatment by Means of Light” issued Sep. 1, 1998; U.S. Pat. No. 6,238,424 of Thiberg for “Device for External Treatment with Pulsating Light of High duty Cycle” issued May 29, 2001 ;U.S. Pat. No. 6,238,425 of Thiberg for “Device for External Medical Treatment with Monochromatic Light” issued May 29, 2001; PCT Publication Number WO 01/68172 of Pederson et al. for “Light Therapy Device” published Sep. 20, 2001).
Many of these devices comprise a plurality of light sources of varying wavelengths that may be affixed to a flexible substrate. Light sources in some of these devices may be pulsed at different rates and operate at different duty cycles (i.e. ratio of time on to time off) and may be arranged in geometrical patterns.
For example, U.S. Pat. No. 6,290,713 discloses a light therapy device having a plurality of light-generating sources on a flexible substrate that uses a controller for controlling selective illumination of the light sources, light intensity and therapy time. The device may be passively or actively cooled, and may have a diffusive, or reflective layer that maximizes the light contacting the covered surface of the patient.
U.S. Pat. No. 6,187,029 describes an ergonomically shaped photothermal treatment device for a number of different anatomical surface positions of the human body. The photo thermal device comprises a plurality of LEDs and resistors housed in a contoured case. The LEDs may be pulsed or fired in a sequence to reduce body adaptation to treatment. A number of possible biochemical and physiological effects are described as relating to the use of the photo-thermal device, including increased oxidative enzyme activities, increased RNA synthesis and enhanced protein synthesis, and increased serotonin production, among others.
U.S. Pat. No. 6,096,066 describes a flexible patch with a plurality of light sources spaced in an array for photodynamic therapy (PDT). A controller may independently control the activation (schedule) of different groups of light sources, as well as their intensity and timing.
U.S. Pat. No. 5,616,140 describes a battery-operated, flexible, conforming portable laser bandage having one or a plurality of lasers and hyper-red light-emitting diodes that may be worn by a patient for treatment of specific body areas. A number of configurations of the device are disclosed, including a glove, sock, wrist band, and clothing. The device may be programmed to initiate operation for particular treatment time periods.
U.S. Pat. No. 5,358,503 describes a light and thermal therapy device comprising a flexible, conforming pad having a plurality of juxtaposed light-emitting diodes, each held in contact with the skin, and resistors to heat each diode. According to the disclosure in U.S. Pat. No. 5,358,503, LEDs are positioned in the device to assure complete coverage of the treatment area. LEDs are arranged in a plurality of rows. Diodes in rows are connected in series with each other and the rows are additionally connected in parallel with other rows. A rheostat controls the light intensity of the diodes as well as the amount of heat generated by the resistors.
U.S. Pat. No. 4,930,504 describes a device comprising a plurality of monochromatic light sources, preferably of three different wavelengths, arranged such that radiation of at least two different wavelengths passes through a single point on a treatment area. This device can be configured in either a single beam probe, or a cluster probe having the light sources arranged in different geometric patterns and further comprises a power supply and a control unit for modulating pulse frequency and treatment time.
U.S. Pat. No. 6,249,698 describes the use of a plurality of energy transducers, including light sources, the output of which is modulated at audio or sub-audio frequencies. The transducers are regulated by a system to control their timing and sequence of operation.
In addition to the photothermal devices discussed above, a number of devices are designed to stimulate one or more acupuncture points. It is also generally believed that light therapy directed at specific acupuncture points is effective at unblocking energy flow in acupuncture meridians. There are several prior art devices which unblock meridians by use of pulsed or continuous light applied to the classic acupuncture points much like the use of needles, magnets or pressure is used at these points to unblock energy flow. (U.S. Pat. No. 6,238,425 of Thiberg for “Device for External Medical Treatment with Monochromatic Light” issued May 29, 2001; U.S. Pat. No. 5,643,173 of Welles for “Method and Apparatus for Stress Relief” issued Jul. 1, 1997; U.S. Pat. No. 4,535,784 of Rohlicek et al. for “Apparatus for Stimulating Acupuncture Points by Light Radiation” issued Aug. 20, 1985; and U.S. Pat. No. 4,553,546 of Javelle for “Assembly for Regulating the Energy Circulating in the Meridians and Method of Use” issued Nov. 1985; and U.S. Pat. No. 6,221,095 of Van Zuylen et al. for “Method and Apparatus for Photon Therapy” issued Apr. 24, 2001.
U.S. Pat. No. 6,238,425 describes a device comprising a plurality of monochromatic light sources wherein one or more wavelengths of light are represented in the plurality. A drive including a selector is also provided for controlling treatment time and pulse frequency of the light sources. The light sources having different wavelengths may be separately controlled, allowing treatment in stages by different wavelength light. U.S. Pat. No. 6,238,425 also describes using the device to stimulate acupuncture points by choosing suitable wavelengths and pulse frequencies.
U.S. Pat. No. 6,221,095 describes a flexible, conforming device comprising a plurality of light sources for directing light to a treatment area and a control unit that may operate in conjunction with a personal computer or independently for portable use. The control unit may store a number of prescribed treatments and may control treatment type, time, etc. The light sources may operate in continuous wave, modulated, or pulsed modes and may be directed to acupuncture points.
U.S. Pat. Nos. 5,643,173; 4,535,784; and 4,553,546 all describe the therapeutic use of light directed at a specific acupuncture point. U.S. Pat. No. 5,643,173 describes a square wave generator for directing a square wave through a human body in combination with LEDs for directing light to pre-selected acupuncture points. U.S. Pat. No. 4,535,784 describes a single light-emitting diode for stimulating an acupuncture point combined with an electrode surface for locating the acupuncture point. U.S. Pat. No. 4,553,546 describes an apparatus for the application of pulsed infrared light to traditional acupuncture points, and further discloses the use of two such apparatuses to stimulate both an inductive acupuncture point and a directive acupuncture point to cause energy to flow in a particular direction.
It is known in the art that ‘tracing’ (e.g. with light touch) the acupuncture meridians, or parts of the acupuncture meridians, can stimulate energy flow along them (Thie, J. F., “A New Approach for Restoring our Natural Energies; 1979.) Such tracing is different from the stimulation of individual acupuncture points, or nodes, located along the meridians to unblock the flow of energy through the individual nodes. There is a need in the art for a device capable of tracing the meridians, or portions of the meridians to stimulate energy flow in them. The device and methods of the present invention satisfy such a need.
All publications referred to herein are incorporated by reference to the extent not inconsistent herewith.